Automates Coma Plus Cocaine Metabolite Assay

FDA 510(k) K923314 · Serex, Inc.

Substantially Equivalent

510(k) numberK923314

Submission

Device name
Automates Coma Plus Cocaine Metabolite Assay
Applicant
Serex, Inc.
Maywood, NJ, US
Received
July 7, 1992
Decision date
August 24, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JXO – Enzyme Immunoassay, Cocaine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Specialty
Clinical Toxicology

Other 510(k)s with product code JXO

510(k)DeviceApplicantDecision
K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairJXO · Traditional Psychemedics Corporation06/25/2021SE
K111925Psychemedics Cocaine EiaJXO · Traditional Psychemedics Corp.05/01/2012SE
K921140STC Diagnostics AUTO0LYTE Cocaine Metabolite EiaJXO · Traditional Solarcare Technologies Corp,Inc.08/20/1992SE
K915785STC Diagnostics Benzoylecgonine EiaJXO · Traditional Solarcare Technologies Corp,Inc.03/11/1992SE
K913737Il Test(Tm) CocaineJXO · Traditional Instrumentation Laboratory CO12/03/1991SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K921834Automates Coma Cocaine Metabolite AssayDIO · Traditional 06/15/1992SE
K901333BETA-2 Microglobulin EiaJZG · Traditional 04/02/1990SE
K895043Coma Cocaine Metabolite Assay (Eia)DIO · Traditional 11/08/1989SE
K890694BETA-2 Microglobulin EiaJZG · Traditional 03/16/1989SE

Questions and answers

When was Automates Coma Plus Cocaine Metabolite Assay cleared by the FDA?

Automates Coma Plus Cocaine Metabolite Assay (K923314) received a 510(k) decision of Substantially Equivalent on August 24, 1992, 48 days after the submission was received.

What is the product code of K923314?

The FDA product code is JXO – Enzyme Immunoassay, Cocaine, a Class II (moderate risk) device regulated under 21 CFR 862.3250.